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Mechanical Thrombectomy for Stroke

Powered by a unique segmental design, our next generation NeuroVasc eNVi™-SR is designed to remain open under tension when retracting through tortuosity and allows interventionalists multiple sizing options and simplified catheter exchange via the included extension wire during mechanical thrombectomy treatment for stroke1,2.

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Features and Benefits

  • Articulating Segments
    Articulating segments are specifically designed to promote clot retention through tortuosity, as shown in in vitro testing published in JNIS1,2,3
  • Radial Force
    Targeted radial force tuned by device diameter enables conformability to the vessel wall1,4
  • Extension Wire Included
    Enables access or exchange when extra length is needed1
  • Tapered Softness
    Allowing for smooth navigation and delivery through tight siphons and cervical loops in the ICA and MCA tortuosity1
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  • Wide Size Range
    Labeled diameters of 3mm to 5mm and working lengths from 10mm to 55mm to treat many situations and anatomies:
    3×10, 3×15, 3×20, 4×25, 4×35, 4×45, 5×30, 5×40, 5×55
  • Up to 5 Retriever Segments
    Providing a variety of solutions for different clots
  • Excellent Visibility
    Multiple radiopaque markers for segment visibility throughout the working length
  • Compatibility with Accessories
    Compatible with other commercially available Microcatheters, optimized when used in conjunction with eNVoke™ Microcatheters5,6,7
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This product is not available in all countries or regions and is not available in the USA. This product and information provided is for use by a Healthcare Professional only, please contact your NeuroVasc Technologies representative for details regarding product availability.

Intended Use, Warnings and Precautions >

1 TR18-001
2 TR18-003
3 Kaneko N, Komuro Y, Yokota H, et al. J NeuroIntervent Surg. 2019;11:119–122. Testing per Kaneko and statements quoted refer to the VERSI Retriever. Articulating segmental design is substantially similar between the VERSI Retriever and ENVI™-SR Retriever.
4 TR20-001
5 TR22-001
6 IFU-020, see product labeling supplied with each device for additional information on compatibility
7 Virani SS, Alonso A, Benjamin EJ, et al.; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics – 2020 Update. Circulation, 2020 Mar 03;141:e139-e596.

ENVI™-SR

CE marked product information

Intended Use

The ENVI™-SR is intended for use to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for IV tPA or who fail IV tPA therapy are candidates for treatment.

Contraindications

Use of the ENVI™-SR is contraindicated under these circumstances:

  • Patients with known hypersensitivity to nickel-titanium.
  • Patients with angiographic evidence of carotid dissection.

Warnings

  • Do not use if damage to the device is observed.
  • Do not use if the product sterile barrier system or its packaging is compromised.
  • Do not resterilize and/or re-use in multiple patients. Structural integrity, sterility and/or function may be impaired by resterilization or re-use.
  • To reduce risk of device damage, vessel damage, and/or patient injury:
    • Select the appropriate ENVI™-SR based on the vessel size to be revascularized.
    • Do not perform more than 3 revascularization attempts in the same vessel.
    • Do not deliver and retrieve the ENVI™-SR more than 3 times.
    • Do not torque the ENVI™-SR.
    • Monitor ENVI™-SR positioning in vessel during exchange to prevent movement.
    • Do not pull the ENVI™-SR through a pre-existing stent or entanglement and vessel damage may occur.

Precautions

  • Carefully read these directions before using this product. Observe warning and safety precautions.
  • For each new Retriever, use a new microcatheter.
  • The appropriate anti-platelet and anti-coagulation therapy should be administered in accordance with standard medical practice.
  • The ENVI™-SR should only be used by physicians experienced in angiographic and percutaneous neurointerventional procedures.
  • Use device prior to “Use-by” date printed on label.
  • Prevent exposure to temperatures in excess of 60°C. Exposure to temperatures above this temperature may damage device and accessories. Do not autoclave.
  • To prevent thrombus formation and contrast media crystal formation, maintain a constant infusion of appropriate flush solution between guide catheter and microcatheter and between the microcatheter and the Retriever or guidewire.
  • Caution: Federal (USA) law restricts this device to sale, distribution and use by or on the order of a physician.

Potential Complications

Possible complications of the use of the ENVI™-SR include, but are not limited to:

  • Adverse reaction to antiplatelet/anticoagulation agents or contrast media
  • Air embolism
  • Arteriovenous fistula
  • Change in mental status
  • Death
  • Device deformation, collapse, fracture, or malfunction
  • Distal embolization including to a previously uninvolved territory
  • Hematoma and hemorrhage at puncture site
  • Infection
  • Intracranial hemorrhage
  • Ischemia
  • Neurological deficits
  • Neurological deterioration including stroke and death
  • Perforation or dissection of vessel
  • Post procedural bleeding
  • Pseudo aneurysm formation
  • Thrombosis
  • Vascular occlusion
  • Vessel spasm
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Facts about Stroke

Stroke is the leading cause of serious long-term disability in the USA, and the 2nd leading cause of death worldwide. According to AHA statistics, there are about 795,000 new strokes per year in the USA alone resulting in 146,383 deaths7,8.

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People living globally who have experienced a stroke8
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New strokes every year8
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Strokes occur in people
<70 years old9
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People die from a
stroke every year8
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People >25 yrs will
experience a stroke
in their lifetime10

8 GBD 2016 Stroke Collaborators. Global, regional, and national burden of stroke, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol, 2019;18:439-58.
9 World Stroke Organization. Global Stroke Fact Sheet. These values have all been extracted from the Global Burden of Disease Stroke Statistics Worldwide for the year 2016.
10 V. Feigin et al. Global, Regional, and Country-Specific Lifetime Risks of Stroke, 1990 and 2016. New Engl J Med 2018;379:2429-2437